Baricitinib - Generic Drug Details
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What are the generic sources for baricitinib and what is the scope of patent protection?
Baricitinib
is the generic ingredient in one branded drug marketed by Eli Lilly And Co and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Baricitinib has one hundred and three patent family members in forty-four countries.
One supplier is listed for this compound.
Summary for baricitinib
International Patents: | 103 |
US Patents: | 6 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 117 |
Clinical Trials: | 123 |
Patent Applications: | 3,522 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for baricitinib |
What excipients (inactive ingredients) are in baricitinib? | baricitinib excipients list |
DailyMed Link: | baricitinib at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for baricitinib
Generic Entry Date for baricitinib*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for baricitinib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of North Carolina, Chapel Hill | Phase 2 |
Healthcare Pharmaceuticals | Phase 2 |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Phase 2 |
Pharmacology for baricitinib
Drug Class | Janus Kinase Inhibitor |
Mechanism of Action | Janus Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for baricitinib
Paragraph IV (Patent) Challenges for BARICITINIB
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
OLUMIANT | Tablets | baricitinib | 4 mg | 207924 | 1 | 2023-10-03 |
OLUMIANT | Tablets | baricitinib | 1 mg and 2 mg | 207924 | 2 | 2022-05-31 |
US Patents and Regulatory Information for baricitinib
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Eli Lilly And Co | OLUMIANT | baricitinib | TABLET;ORAL | 207924-002 | Oct 8, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Eli Lilly And Co | OLUMIANT | baricitinib | TABLET;ORAL | 207924-001 | May 31, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Eli Lilly And Co | OLUMIANT | baricitinib | TABLET;ORAL | 207924-003 | May 10, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Eli Lilly And Co | OLUMIANT | baricitinib | TABLET;ORAL | 207924-002 | Oct 8, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Eli Lilly And Co | OLUMIANT | baricitinib | TABLET;ORAL | 207924-002 | Oct 8, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Eli Lilly And Co | OLUMIANT | baricitinib | TABLET;ORAL | 207924-003 | May 10, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for baricitinib
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Eli Lilly Nederland B.V. | Olumiant | baricitinib | EMEA/H/C/004085 Rheumatoid arthritisBaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Olumiant may be used as monotherapy or in combination with methotrexate.Atopic DermatitisOlumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy.Alopecia areataBaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5.1).Juvenile idiopathic arthritisBaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs:- Polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular),- Enthesitis related arthritis, and- Juvenile psoriatic arthritis.Baricitinib may be used as monotherapy or in combination with methotrexate. |
Authorised | no | no | no | 2017-02-13 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for baricitinib
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Slovenia | 2288610 | ⤷ Sign Up | |
Poland | 2830662 | ⤷ Sign Up | |
Croatia | P20181976 | ⤷ Sign Up | |
Uruguay | 31705 | DERIVADOS DE AZETIDINA Y CICLOBUTANO COMO INHIBIDORES DE JAK | ⤷ Sign Up |
Costa Rica | 11640 | DERIVADOS DE AZETIDINA Y CICLOBUTANO COMO INHIBIDORES DE JAK | ⤷ Sign Up |
Spain | 2746554 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for baricitinib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2288610 | PA2017023 | Lithuania | ⤷ Sign Up | PRODUCT NAME: BARICITINIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/16/1170 20170213 |
2288610 | 2017033 | Norway | ⤷ Sign Up | PRODUCT NAME: BARICITINIB OG FARMASOEYTISK; REG. NO/DATE: EU/1/16/1170 20170222 |
2288610 | SPC/GB17/045 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: BARICITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/16/1170/001(NI) 20170215; UK EU/1/16/1170/002(NI) 20170215; UK EU/1/16/1170/003(NI) 20170215; UK EU/1/16/1170/004(NI) 20170215; UK EU/1/16/1170/005(NI) 20170215; UK EU/1/16/1170/006(NI) 20170215; UK EU/1/16/1170/013(NI) 20170215; UK EU/1/16/1170/014(NI) 20170215; UK EU/1/16/1170/015(NI) 20170215; UK EU/1/16/1170/016(NI) 20170215; UK PLGB 14895/0255 20170215; UK PLGB 14895/0256 20170215; UK EU/1/16/1170/007(NI) 20170215; UK EU/1/16/1170/008(NI) 20170215; UK EU/1/16/1170/009(NI) 20170215; UK EU/1/16/1170/010(NI) 20170215; UK EU/1/16/1170/011(NI) 20170215; UK EU/1/16/1170/012(NI) 20170215 |
2288610 | C20170022 00232 | Estonia | ⤷ Sign Up | PRODUCT NAME: BARITSITINIIB;REG NO/DATE: EU/1/16/1170 15.02.2017 |
2288610 | 122017000045 | Germany | ⤷ Sign Up | PRODUCT NAME: BARICITINIB; REGISTRATION NO/DATE: EU/1/16/1170 20170213 |
2288610 | 655 | Finland | ⤷ Sign Up | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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